About This Role
This role involves driving global regulatory strategies and ensuring compliance throughout the product lifecycle of innovative cardiovascular medical devices. The specialist will work closely with cross-functional teams to support product development, regulatory submissions, design changes, and market access, playing a key role in bringing life-changing technologies to patients worldwide.
Responsibilities
- Prepare, review, and maintain regulatory submissions and registrations for medical devices in global markets, with a primary focus on the U.S. (FDA) and European Union (EU MDR)
- Support regulatory strategy development for new product introductions, design changes, and lifecycle management activities
- Manage Engineering Change Orders (ECOs) from a regulatory perspective, including assessment of regulatory impact, documentation updates, and submission requirements
- Compile, maintain, and update technical documentation, regulatory dossiers, and supporting documentation in accordance with regulatory requirements
- Ensure compliance with EU MDR, FDA regulations, and applicable international standards throughout the product lifecycle
- Monitor changes in regulatory requirements and assess their impact on existing and future products
- Collaborate cross-functionally with R&D, Quality Assurance, Clinical, Manufacturing, and Marketing teams to ensure regulatory compliance
- Support regulatory assessments, risk management activities, labeling reviews, and design change evaluations
- Participate in audits and inspections and provide regulatory support for quality management system activities
- Maintain regulatory records and ensure timely renewals, registrations, and submissions
Requirements
- Bachelor's degree in Life Sciences, Biomedical Engineering, Engineering, Pharmacy, or a related field
- 4–8 years of Regulatory Affairs experience within the medical device industry
- Proven experience with medical device regulatory submissions and registrations in the United States and Europe
- Strong knowledge of FDA medical device regulations and European Medical Device Regulation (EU MDR 2017/745)
- Hands-on experience managing product changes and ECO processes from a regulatory affairs perspective
- Familiarity with ISO 13485, ISO 14971, and other applicable medical device standards
- Experience supporting product development, design changes, and post-market regulatory activities
- Excellent organizational, analytical, and communication skills
- Strong written and verbal English communication skills
- Ability to work independently and effectively within a multidisciplinary environment
- Experience in the cardiovascular medical device field
